EMA Publishes Proactive Disclosure Guidance
On 2 March 2016, the European Medicines Agency (EMA) published guidance on aspects of the Agency’s proactive disclosure policy for clinical reports (Policy 0070). The latest Proactive Disclosure...
View ArticleAnother round of upcoming amendments to the medicines laws in Germany –...
On 11 November 2016, the German Parliament passed another new law amending different parts of the German Medicines Act (Arzneimittelgesetz) and the Act on Advertising for Healthcare Products...
View ArticleThe Implications of the GDPR on Clinical Trials in Europe
On October 22, 2018, the European Federation of Pharmaceutical Industries in cooperation with the Future of Privacy Forum and the Center for Information Policy Leadership organized a workshop entitled...
View ArticleEMA Publishes Guidance on Clinical Trial Conduct During COVID-19 Pandemic
On 20 March 2020, the European Medicines Agency (EMA) published Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic (the Guidance). The EMA jointly developed the...
View ArticleIreland’s HPRA to fast-track review of Covid-19 related Clinical Trials and...
The Irish Health Products Regulatory Authority (HPRA) today announced the introduction of an expedited review process for human health research related to COVID-19. The Irish Minister for Health also...
View ArticleCommission Publishes Further Guidance on Clinical Trial Conduct During...
On 28 April 2020, the European Commission published further Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) Pandemic (the “Guidance”), supported by the European...
View ArticleComprehensive Amendments of German Drug Laws upcoming
Recently, the German Federal Ministry of Health published a new draft law (“Viertes AMG-Änderungsgesetz”) which aims to amend several provisions of the German Drug Act (Arzneimittelgesetz) and other...
View ArticleLegislative Proposals for Clinical Trials Aim to Streamline, Simplify and...
On 21 March 2023, the UK Government published its response to the consultation on legislative reform proposals for clinical trials that took place from January to March 2022. The current legislation...
View ArticleEU Talking Life Sciences Audiocast: Clinical Trial Transparency Requirements...
The EU Clinical Trials Regulation 536/2014 significantly expanded the transparency requirements for clinical trials in the EU, resulting in the public availability of most documents and information...
View ArticleGermany will revise laws for clinical trials with pharmaceuticals, medical...
Significant changes are on the horizon for clinical trials in Germany. At the end of January 2024, the German Federal Health Ministry has presented the draft for a “Medical Research Act”...
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